efficacy and safety of subcutaneous dupilumab in participants with asthma/asthmatic wheeze aged 2 to <6 years (liberty asthma trekids)

Conditions: Wheezing; Asthma

Summary: this is a parallel, phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. the study will be conducted in 2 parts. part a will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. at the end of part a, all eligible participants will be offered participation in part b, an optional open-label extension phase. study details include: part a: the study duration of part a will be up to 68 weeks consisting of a 4-week screening, a 52week treatment period, and a 12-week post-treatment follow-up period. for participants who will chose to participate in part b, the study duration will be up to 120 weeks (additional 52-week treatment period). part b: for participants who will choose to participate in part b, the study duration will be up to 120 weeks (part a \[4-week screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

the duration per participant is up to 120 weeks.

Eligibility criteria:
inclusion criteria: * participant must be 2 to \<6 years of age * diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ics for at least 3 months with stable use of at least low dose ics for ≥1 month prior to screening visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze. * at least one additional major criterion from the modified asthma predictive index: 1. physician diagnosed atopic dermatitis, 2. allergic sensitization to at least 1 aeroallergen (with a positive serum ige defined as a value ≥0.35 ku/l). or 2 minor criteria: 3. wheezing unrelated to colds, 4. peripheral blood eosinophilia ≥4%, 5. allergic sensitization to milk, eggs, or peanuts (defined by serum specific ige \>0.35 ku/l. * parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures. * parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements. * participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires * body weight at screening and randomization \>5 kg and \<30 kg. * parents or caregivers or legal guardian capable of giving signed informed consent. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * severe asthma with the need for chronic oral/systemic corticosteroid use (\>1 month continuous) at the time of screening enrollment. * history of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient. * history of prematurity (\<34 weeks gestation). * any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period. * history of life-threatening asthma (eg, requiring intubation). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.